CLYDESDALE PTC™ Spinal System 4922045Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169190801), received between Jan 4, 2018 and Dec 4, 2023 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING UNKNOWN SPINAL THERAPY AT L2/3/4/5 FOR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT THE INTERVERTEBRAL SPACE WAS NARROW, SO THE CAGE BROKE DUE TO A PRYING OPERATION. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18254522 ↗
• MalfunctionMar 17, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. PROCEDURE OR THERAPY PERFORMED WAS L1-L2 DLIF. IT WAS REPORTED THAT WHILE IMPLANTING THE CAGE INTO THE PATIENT, THE THREADED PART OF THE CAGE PROXIMAL TO THE INSERTER TIP BROKE OFF. THE THREADED PORTION BROKE OFF AND STAYED ON THE INSERTER, A FEW OTHER PIECES BROKE OFF AND THEY WERE RECOVERED FROM THE PATIENT. CAGE COULD NOT BE REMOVED AT THIS POINT, WAS OVER HALFWAY INTO THE DISC SPACE AND THEREFORE THE CAGE WAS LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. NO BROKEN FRAGMENTS WERE LEFT INSIDE THE PATIENT ALSO RETRIEVED THE THREADED PORTION AROUND THE INSERTER AND THE OTHER TWO BROKEN FRAGMENTS FROM THE CAGE. NO ADDITIONAL SURGERY IS PLANNED TO EXPLANT THE CAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13796404 ↗
• MalfunctionSep 6, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LATERAL INTERBODY FUSION(OLIF) SURGERY AT L2/3 DUE TO DEGENERATIVE SCOLIOSIS. INTRA-OP, WHILE INSERTING THE CAGE AT L2/3, ONE THIRD OF THE CAGE WAS BROKEN WHEN HALF OF THE CAGE WAS IN THE PATIENT. THE SURGEON TRIED TO REMOVE THE CAGE, BUT FAILED. THE ANTERIOR TWO THIRDS OF THE CAGE WAS CONTINUED TO BE IMPLANTED. THERE WAS A DELAY OF LESS THAN A 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. PATIENT COMPLICATIONS WERE UNKNOWN AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8968741 ↗
• InjuryMay 7, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AT L2-L5 DUE TO KYPHOSCOLIOSIS. ON (B)(6) 2019, POST-OP, DURING POSTERIOR FIXATION, THE SURGEON NOTICED THAT THE CAGE PLACED AT L3-L4 MIGRATED ANTERIORLY TOWARDS THE APPROACH SIDE (LEFT) ABOUT HALF. IT WAS WHEN SURGEON WAS PERFORMING POSTERIOR SCREW FIXATION, SO THE SURGEON HAD TO CLOSE THE WOUND TO STOP THE SURGERY. THE SURGEON THEN PLACED THE PATIENT IN LATERAL POSITION AND OPENED THE WOUND IN OLIF APPROACH TO REPOSITION THE MIGRATED CAGE WITH INSERTER. AFTER THAT HE CLOSED THE WOUND. THE SURGEON THEN RESUMED POSTERIOR FIXATION AND WENT ON TO COMPLETE THE SURGERY. TH4-S2AI FUSION WAS COMPLETED AS PLANNED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8587323 ↗
• InjuryMar 12, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF) AT L3/4 DUE TO AUTONOMIC DYSREFLEXIA (ADS). POST-OP, THE IMPLANTED CAGE BACKED OUT FOR ABOUT 1/2 OF ITS SIZE. PATIENT UNDERWENT REVISION SURGERY WHERE THE ALLEGED IMPLANT HAS BEEN REMOVED, AND A BIGGER SIZE ONE WAS INSERTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8411092 ↗
• InjuryAug 1, 2018Device Dislodged or Dislocated; Migration; Migration

  PROCEDURE: OBLIQUE LUMBAR INTERBODY FUSION (OLIF) LEVELS IMPLANTED: L3-L4 IT WAS REPORTED THAT THE PATIENT PRESENTED WITH KYPHOSCOLIOSIS. POST-OP, REVISION SURGERY WAS PERFORMED FOR HAMMERING THE CAGE AGAIN AS THE CAGE AT L3-L4 BACKED OUT. ON (B)(6) 2018, FUSION WAS ALSO PERFORMED AT T10-S2.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7739498 ↗
• MalfunctionJan 4, 2018Difficult to Insert; Difficult to Insert

  PRE-OP DIAGNOSIS: POSTERIOR SCOLIOSIS PROCEDURE: OBLIQUE LUMBAR INTERBODY FUSION(OLIF), LATERAL LUMBAR INTERBODY FUSION(XLIF) LEVELS: L2/3/4/5 IT WAS REPORTED THAT DURING SURGERY, THE CAGE WAS ALLEGEDLY REPORTED BROKEN. AFTER THE CAGE WAS INSERTED USING AN INSERTER THAT HAS SLEEVES, THE CAGE WAS REMOVED USING A REMOVER TO ADJUST ITS POSITION. WHEN THE CAGE WAS ATTACHED TO THE INSERTER TO REINSERT, THE FORCE GRASPING THE CAGE WAS FOUND TO BE WEAK. THE CAGE WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7163222 ↗